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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CPAP/AUTOPAP NO FITTING MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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CPAP/AUTOPAP NO FITTING MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583)
Patient Problems Dehydration (1807); Confusion/ Disorientation (2553); Alteration in Body Temperature (4568)
Event Date 06/06/2021
Event Type  Injury  
Event Description
Continuous poor mask fit on cpap device lead to severe dehydration in elderly man.Which lead to fugue states and heat exhaustion.He has completely stopped sweating as a result of the mask problems.This problem started in april with second covid shot.Then recurred anytime exposed to heat or exertion.As new machine/mask continued to leak.By end of june we realized he could no longer sweat and although he now has a better fitting mask, he has only experienced sweat one time and is still at risk of heat exhaustion and heat stroke if not prevented from getting hot.Multiple blood tests, mri, etc.The not-sweating is observable.The exertion/confusion link also observed.The tank on the machine would be dry night after night.Fda safety report id # (b)(4).
 
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Brand Name
CPAP/AUTOPAP NO FITTING MASK
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
MDR Report Key12239629
MDR Text Key264591738
Report NumberMW5102823
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 07/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/27/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Disability;
Patient Age83 YR
Patient Weight70
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